MEDICAL PLASTICS news
+ FEMTECH - WHAT IS IT? M&A ACTIVITY – WHERE ARE WE? WHAT ARE SOFT ROBOTICS?
Upside-down thinking
ENGEL’S NOVEL TAKE ON CLEANROOM MOULDING ISSUE 37
Jul-Aug 2017
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CONTENTS July-August 2017, Issue 37
Regulars
Features
5 Comment Why are women being shortchanged?
19 Come together A look at a years’ worth of M&A activity and Spectrum Plastics offers an insight into its own experience
6 News focus The NICE online tool to show your medical device is clinically sound and cost-effective
33 Clean living Connect 2 Cleanrooms, looks at off-site construction and the future of cleanrooms
8 Digital spy
22 D esign for life Teleflex Medical OEM provides expertise on designing a catheter to achieve optimal performance
36 Talking tech Intellectual property law firm Gill Jennings & Every LLP asks what makes a digital health business a medtech business?
11 News focus Why medical device regulation should cut the jargon and Mistubishi Electric’s take on Industry 4.0
25 An inspector calls Laser Design takes a look at the importance of part scanning and inspection within the overall production schedule
38 Girls just wanna have femtech Nelson Labs look at third-party reprocessing of single-use medical devices
14 News analysis What Mediplas@Interplas has to offer the medical device manufacturer
27 Clean lines Choosing the right decontamination method for syringe tubs entering the filling line courtesy of Noxiliser
16 Cover story Engel takes a novel view on cleanroom moulding
30 Bend me shape me Lu Rahman looks at the new wave of robotics. Soft and pliable these new devices take their inspiration from nature
40 Round trip Raumedic discusses coextrusion technology and Natvar explains how the new generation of microextrusion medical tubing opens doors to new procedures
46 08:2017
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CREDITS
EDITOR’S
group editor | lu rahman
comment
deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com
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ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)
T
On the a-gender
here’s been a lot of press in the UK of late about gender pay gaps – and rightly so. With corporations such as the BBC being hauled over the coals for the discrepancy in male and female wages, it has become a hot topic for the media and one which doesn’t look like it’s going to disappear any time soon. A quick delve into recent news stories on this topic and it’s all too clear that the BBC isn’t the only establishment short-changing women. According to the FT, PwC was found to be paying its female staff 14% less than its male members and in a survey carried out by Glassdoor, the pay gap between the sexes in the UK is around 5.5%. In the US Glassdoor reported that the biggest discrepancy in pay can be found in the programming sector. It’s disappointing reading. I’m sure I’m not alone in thinking that companies should play fair and that you’d think the bigger ones would lead the way. It’s hard not to feel disheartened. Taking a look at women in the medtech sector in general, and the way they are represented at board level, the sinking feeling deepens. In search of statistics on women rising to the top of medical technology companies, the findings were pretty grim, although I guess not wholly surprising given the reluctance many businesses have in promoting women to key top-level roles.
including expertise in finding opportunities, ability to network, a gift for cultivating relationships and a tendency towards giving along with having a social conscience. Despite this, the Guardian headline from March 2015, says it all – ‘Fewer women leading FTSE firms than men called John’. Two years on and the picture isn’t looking much rosier. According to The Pipeline’s annual Women Count report there has been no progress in the last year where the number of women on executive committees is concerned. But it isn’t all doom and gloom. Looking at the rise of the femtech sector medical devices and digital health technology for female healthcare – there are a significant number of women behind these businesses. It’s a growing and highly profitable market that is being highlighted as holding significant opportunity for those involved. Hopefully, thanks to the numbers of start-ups headed up by women, we’ll start to see a change in attitudes towards women and a rise in the numbers of females involved in board level business decisions. Let’s hope their pay also starts to match their positions.
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Taking a look at women in the medtech sector in general, and the way they are represented at board level, the sinking feeling deepens
In 2011 Forbes reported on a survey by Pepperdine University that found that women in top positions were beating industry averages for productivity and profitability. The article also highlighted key attributes that women bring to the workplace WWW.MEDICALPLASTICSNEWS.COM
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NEWS FOCUS
How to show your medical device is
clinically sound and cost effective
T
oday thousands of start-ups, academic centres and small and large companies are inventing and developing medical devices, NICE’s online diagnostic tests and health tool helps product apps at an ever-increasing developers pace. Will the market have understand and the capacity to absorb and adopt the new technologies? generate the Will these technologies make evidence needed a real difference to patients? to show that their Can these technologies save products are resources for cash-strapped healthcare systems?
clinically sound and cost-effective
Consumers might be persuaded to pay for a product based on marketing slogans, but when it comes to procurement in cash-tight health services, promises, packaging, and sleek design become insufficient. Payers want to be reassured with robust clinical evidence and the economic rationale that they are acquiring products which generate savings and improve quality of care. Technologies of different classes require various levels of evidence packages to convince the payers of their value proposition. Many developers of devices, diagnostics and health apps are unaware of the reimbursement requirements, especially in the earlier stages of product development, or are unable to formulate or narrow down the value proposition for their products to become attractive for national or regional reimbursement. Evidence generation is expensive and for product developers it makes sense to do all they can to make this process as efficient as possible. Where feasible, companies are encouraged to initiate early dialogues with regulatory authorities and payers to ensure
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that the evidence generation plans meet key stakeholder requirements. But in many cases, companies are unable to progress towards such detailed discussions for a number of reasons. These can include the inability to formulate relevant questions, early development stages, lack of time and resources, or the lack of relevant staff to lead such engagements, etc. In July 2017 NICE Scientific Advice launched a new service - an online tool to help product developers understand and generate the evidence needed to show to the payer that their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool has been brought to market in partnership with Greater Manchester Academic Health Science Network. The tool helps companies efficiently and affordably identify what evidence they already have and what gaps need to be filled to satisfy payer requirements. This process aims to help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market. The original version of the META tool is designed for the UK market and is a paid for service aimed at, but not limited to, small and medium sized companies. Developers can use the service at any time in the product development cycle and it is suitable even for products which are already in the market but which are unable to gain relevant adoption levels in the healthcare system. META provides a rapid assessment of the product to highlight gaps in the evidence via a discussion with a trained facilitator. A key output from the META tool is a set of future steps for the developer to help with their future market access strategy. Importantly,
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undergoing the META process may help some organisations make decisions about discontinuing or modifying their product development plans. The META tool can be licensed for use by partner organisations working with medtech companies. These could include Academic Health Science Networks, Healthcare Technology Consortiums and consultancies who may have their own bespoke approaches to using META and assisting product developers prepare their products for adoption into a healthcare setting. This accessibility will maximise META’s potential and make it available to companies not just in the UK but internationally as well. Consulting companies and other organisations interested in acquiring META licenses from NICE receive relevant training and accreditation. NICE’s aim for the META tool is to reach out to as many medtech companies as possible to help them understand whether technologies that they are developing are transformative and cost-saving to the healthcare systems and if so, offer further steps on how to demonstrate the value of their technologies to patients and payers with robust clinical and economic evidence. We look forward to working with international companies interested in bringing their products into the NHS in the future. Those companies willing to engage in a more detailed dialogue with NICE are encourage to use our standard or light advice processes or the newly introduced advice procedure with the FDA and the US payers. www.nice.org.uk
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DIGITAL
DIGITAL NEWS
spy
Close to the BONE: RESEARCHING INNOVATIVE BONE IMPLANTS
www.maastrichtuniversity.nl/pers
TECHNOLOGY UPDATE
A
www.invibio.com
In it to win it:
INVIBIO AND CARBOFIX TEAM UP WITH UK SPRINTER FOR TRAUMA IMPLANT
U
K Olympic sprinter James Ellington has joined forces with the UK´s Invibio Biomaterial Solutions and CarboFix Orthopedics on his road to recovery. His ambition is to return to the world stage of athletic competition after a motorcycle accident in Tenerife. The two companies and the athlete share a passion for pushing boundaries; for James Ellington, mentally and physically first in sport and now in recovery, and for CarboFix and Invibio with innovative biomaterials and devices that have the potential to change the treatment of trauma fractures. For patients recovering from traumatic injuries this could serve as an inspiration not to lose track of their goals and passion. “In extreme situations, it’s important not to lose faith and to consider all (therapeutic) options available,” explained Ellington. “I had a severe tibia fracture, and was offered two choices to fix it: a traditional titanium nail or a CarboFix nail using a relatively new, but promising carbon fibre, composite technology. For me, it’s all about giving myself the best chance of achieving my goal and returning to competitive athletics. I chose the CarboFix nail because
it’s lighter weight and for its faster healing potential.” “The rod is made from a new composite polymer. It’s strong, in a way that’s similar to metal implants, but not as stiff, which means it has the capability to stress the bone more and provide some micro-motion, so it works more like natural bone. The idea is that this will help support a quicker recovery – which is what convinced me this was the right path for me.” With trauma implants made from Invibio’s PeekOptima Ultra-Reinforced, a composite polymer, CarboFix Orthopedics is hoping to support Ellington and other patients in a similar position. Ron Szekely, the company´s vice president of sales and marketing, said: “The aim itself to get back on track is fantastic, whether that’s the athletic track or returning to other individual recovery goals. This can be an important driver for rehabilitation. In addition to dedication and enthusiasm, patients need to have access to innovative medical devices that can support this. At CarboFix we believe in the potential of changing trauma treatment to improve the quality of life for many patients.”
European transnational consortium led by Maastricht University (UM) will spend the next four years developing innovative bone implants. These implants will become an alternative for repeat surgeries, prolonged medication use and donor tissue implementation following complex bone fractures. The Biofabrication of Orthopaedics in a New Era (BONE) partnership will also provide the participating regions with a significant economic boost. (France). Bone implants and consortium Research shows that residents of Northwestern Europe are more likely to develop degenerative bone disorders in comparison to their EU counterparts. As a result, this region has the highest number of bone fractures and bone defects within Europe. Regenerative medicine researchers have been working to create innovative bone implants that can enhance recovery times and reduce healthcare costs.
“We want to improve the surface properties of the bone implants in a way that ensures the success of the regeneration process,” says Lorenzo Moroni, professor of biofabrication for regenerative medicine at UM. “That’s why we’re combining electrospinning with other technologies. An added advantage is that this will help us expand the library of suitable materials for smart bone implants.”
Technology At the basis of these smart bone implants lies an innovative
DIGITAL SPY
www.lucideon.com Lucideon aids search for new antibacterial materials
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ucideon, has welcomed five researchers from the Institute of Biomaterials, Friedrich Alexander University Erlangen, Nuremberg, to its headquarters in Stoke-on-Trent, UK to develop new antibacterial materials. Lucideon is one of nine companies, clinics and universities involved in the HyMedPoly project ‘Drug-Free Antibacterial Hybrid Biopolymers for Medical Applications’, a collaboration training PhD researchers in the development of drug-free antibacterial materials used for medical applications, such as wound care and implants.
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technology, known as electrospinning. This technology enables researchers to create implants that have the potential to help the regeneration of healthy bone tissue.
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Stuart Maclachlan, head of research and development at Lucideon and the HyMedPoly project manager, said: “It’s great to have the researchers at Lucideon and to see them settling into their projects. They’re learning new skills working with our materials development teams and they’re bringing a lot to the company too. “HyMedPoly covers a vital area of research. Infection has become one of the toughest problems in the medical world. As bacteria become more resistant to drugs and there are fewer effective antibiotics, new materials with intrinsic antibacterial properties have an important role.”
DIGITAL SPY
DIGITAL NEWS
www.steritouch.com/
True to type: Medical grade keyboard launched A
ntimicrobial specialist SteriTouch has launched a medical grade keyboard for the healthcare, dental and cleanroom sectors. The SteriType keyboard is washable and features an integrated silicone cover, preventing the need for a separate cover. A washable, antimicrobial mouse is also available.
talking
POINT
A SteriTouch compound of white Magnum ABS with ready-qualified antimicrobial properties forms the body of the keyboard, yielding an independent test result of 99.99% efficacy against MRSA and E.Coli. The silicone cover is coated in silk polyurethane containing SteriTouch antimicrobial powder additive, creating a tactile, soft touch feel.
Easy Listening ‘MEDTALK’ PODCAST LAUNCHES FOR MEDTECH, DIGITAL HEALTH AND PHARMA COMMUNITY What’s so different about this podcast? Well, ever heard of inhalable chocolate? Do you know the link between F1 and infant care? Want to know what ‘femtech’ means? This podcast answers all these questions and more. The podcast, initially a monthly production, will provide an informal discussion on the latest innovations for the healthcare sector.
MATERIAL UPDATE MATERIAL UPDATE
Spanish steps CIKAUTXO OPENS NEW MANUFACTURING PLANT
www.cikautxo.es
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ikautxo Medical is opening a manufacturing plant near its headquarters, in the Basque Country. This 3,000 m² building includes 600 m² of ISO class 7 and 8 cleanroom facilities. “Based on decades of expertise in chemistry and raw materials, Cikautxo Medical develops and manufactures a range of thermoplastics, silicones and high temperature components for the medical device and pharmaceutical industries. High-tech systems for vascular access catheters, enteral feeding catheters,
And who’s behind it? The editors of four of the medical sector’s leading publications. The team behind the MedTalk podcast are Lu Rahman, group editor, Medical Plastics News, Fliss Thomas, editor of European Pharmaceutical Manufacturer, Reece Armstrong, reporter on Digital Health Age, and Dave Gray, editor of Med-Tech Innovation magazine. So why should we listen to it? Episode one, which is available now, looks at the rise of ‘femtech’, the emerging field of connected medical devices aimed at feminine health. The team also looks at the liquidation of Jawbone – formerly one of the major brands in wearable fitness trackers – and what it signals about the rapidly changing digital health sector. Other innovations featured in episode one include inhalable chocolate and an infant transport device which borrows from Formula 1 technology.
urology catheters, injection moulded joints and valves and silicone tubing will be manufactured in this new facility. Cikautxo has invested approximately 8 million euros in the construction of the new building,” said Iker Principe, CEO of the company.
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Why now? Dave Gray explains: “We wanted to bring our four media brands together to create something for anyone with a stake in the life sciences and healthcare industry. “Increasingly our sectors are converging and we find ourselves discussing crossover content on a daily basis. These discussions often provoke further debate and great content ideas – so we thought the time was right to translate that into a podcast. “We also really wanted to keep things quite light. This podcast is really just a recording of our editorial meeting – hopefully it will engage others with an active interest in health and medicine technology.” 9
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NEWS ANALYSIS
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he medical device industry must develop a ‘common language’ within its data systems to ensure full legal compliance and internal traceability. Vendors, medical device manufactures and regulatory Manufacturers and vendors bodies must work together to ensure standardised within the medical device data is captured across the industry must establish a industry. This is according to ‘common language’ to allow quality management provider, information to become InfinityQS.
integrated and aggregated throughout the supply chain, says InfinityQS
The recent passing of the EU Medical Device Regulation (MDR) on 5th May 2017 means any organisation associated with the medical device industry must fully comply with rulings by January 2020. Designed to establish a ‘…regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation,’ the MDR fails however to establish a unified approach to the classification and criteria of medical devices across the supply chain.
“The real challenge for an industry as large as this one, across member states and the UK, is developing a universal language that can be used for internal traceability right along the supply chain. This encompasses everything from vendors, right through to the hospitals where the end product is used,” says InfinityQS. A single common language enables data acquisition and interchange along the supply chain to establish how data is stored and transmitted between entities. In support of this, data analytics enables traceability right across the supply chain to pinpoint the source of a faulty product. A common language delivers greater collaboration between the medical device industry and technology providers as the two work together. “With any number of organisations using different technologies and systems across any one supply chain – SAP, Infor, Microsoft Dynamics – it can be very difficult for disparate IT systems to work and communicate together. By developing a single, unified system then collaboration and traceability are much easier across the supply chain,” InfinityQS concludes.
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NEWS FOCUS
How to achieve Industry 4.0 goals
T
he vision of Industry 4.0 presents a utopia interlinking all parts of an operation and where efficiencies, cost reductions and productivity increases can be achieved through integrated automation.
Industry 4.0 is the manufacturing buzz phrase and we’re told the road to digitalisation is the way forward. Chris Evans, Mitsubishi Electric, reveals how to create the smart factory and achieve Industry 4.0 goals
Mitsubishi Electric has embraced the smart factory and Industry 4.0 concepts. It has distilled this guidance into a white paper, ‘Industry 4.0 – The road to digitalisation in future manufacturing’.
“Most plants in the UK haven’t had the luxury of being designed from scratch to meet the goals of Industry 4.0 but that doesn’t mean it can’t be done,” concluded Evans. “With strategic planning and a structured approach, any plant can reap the benefits of optimised, sustainable, safe production that is energy efficient, all within a fully connected supply chain. The road to digitalisation begins with the first step.”
Mitsubishi Electric marketing & operations group manager, Chris Evans, said: “When we start to consider Industry 4.0 it can be confusing. On one level we are looking at the convergence of business systems with the physical plant control but is this new? The real impetus behind Industry 4.0 comes not just from the link between the plant and the enterprise but once we have this link, not only can we have the means to improve performance but also to measure performance against an ideal model – the cyber physical system, if you will.” In-depth analysis and continuous improvement define the spirit of Industry 4.0 - but how do we get there and is UK manufacturing ready to be smart? “If we built a plant from the ground up on a greenfield site, we could build a smart factory embodying the goals of Industry 4.0, using technologies available today,” Evans commented. “However the challenge with many manufacturing plants is that their automation systems have evolved over years, resulting in disparate automation platforms, poor network infrastructure, no data management strategy and little knowledge of how to get relevant information out. “You have to define exactly what the manufacturer is trying to achieve, its drivers and problems. Look at existing automation and what network infrastructure is in place, if any. Accept it will take time and investment. Look for quick wins that demonstrate returns against a moderate budget.” Mitsubishi Electric has undertaken smart factory implementations at its own facilities. At its Kani Works switchgear production facility, a smart factory upgrade increased productivity and an operating rate plus a reduction in the number of stages in the manufacturing process.
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The vision of Industry 4.0 presents a utopia interlinking all parts of an operation
In its white paper Mitsubishi Electric defines the basis of Industry 4.0 and the overlapping principles of interoperability, information, integration, automation and autonomy. It defines the key features of Industry 4.0, looking at the importance of communications, cyber physical systems and cyber security.
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MEDIPLAS @INTERPLAS
In the zone:
Why the medical plastics world should visit Interplas
T
he UK medical device sector is at the forefront of technology. For medical plastics suppliers it offers a valuable opportunity to be part of an industry that combines the latest in research, The countdown is on to this science, and technology as as having a direct link on year’s Interplas show. The well the health and well-being of the event, which takes place on population. 26-28 September at the NEC, “The UK device market is Birmingham, UK, will feature strong - according to Emergo, is the third largest in Europe. the Mediplas@Interplas itWith around 3,000 medical exhibitor zone and conference device companies operating stream offering visitors the in the UK, and many large US opportunity to meet with the companies using the country a base for the subsidiaries, sector’s key suppliers and as the UK offers opportunities for hear its key players the entire medical device supply chain, particularly in the areas of imaging, cardiovascular and diagnostics. “Within this framework, Medical Plastics News will be hosting the Mediplas@Interplas zone. It’s a great opportunity for visitors to hear a range of high quality experts discuss issues that are making and will make a difference to their business now and in the future,” said Lu Rahman, group editor, Medical Plastics News. The Mediplas@Interplas conference will take place on the afternoon of Wednesday 27 September. “I’m highly excited to have professor Dan Clark, Centre for Healthcare Equipment and Technology Adoption (CHEATA) who will be explaining how businesses can make their medical device NHS-ready. This type of sound advice is crucial to medical device designers and manufacturers who need to look to the NHS from the offset to achieve long-lasting business success,” explained Rahman. Another expert the Medical Plastics News team is thrilled to have on board is Jane Gardner, PVCMed Alliance. “She’ll be sharing her expertise with visitors on how healthcare can contribute to the circular economy. It’s always important that manufacturing companies consider their social and ecological impact and we’re seeing increasing numbers of businesses wanting to know more about the circular economy and how to be part of it,” Rahman said.
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She adds: “Having Alexander Seifalian, director & professor of nanotechnology & regenerative medicine, the London BioScience Innovation Centre, on board is a major coup for us. His medtech credentials are exemplary and he boasts the development of the world’s first synthetic trachea as one of his many achievements. He was awarded the European Life Science Awards winner for this as the most innovative product in 2012. “Seifalian’s presentation promises a valuable look at the future of materials in biomedicine and how the next generation of plastics will be based on carbon-based nano materials. “It’s a stellar line-up and we look forward to seeing many of the medical plastics and device communities there.”
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IN THE ROUND: Jane Gardner, PVCMed Alliance, will be explaining how healthcare can contribute to the circular economy
READY OR NOT: Dan Clark, CHEATA, will be explaining how businesses can make their medical device NHS-ready
FUTURE PROOF: Alexander Seifalian, the London BioScience Innovation Centre will look at how the next generation of plastics will be based on carbon-based nano materials
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COVER STORY
Upside-down thinking Helene Schöngruber and Christoph Lhota, Engel Austria, outline a new cleanroom concept with reversed airflow for high temperature applications
H
igh temperatures are not wanted in cleanrooms, however, in the injection moulding process they are unavoidable. Research on the influence of mould temperature by laminar clean airflow underlines the significance of this subject and lays the foundation for a new cleanroom concept with reversed airflow. The first industrial installations promise much potential for even higher cleanroom quality.
For injection moulding of thermoplastics, the resin pellets are heated in the barrel until they have reached a viscous or liquid state and are then injected into the temperature-controlled mould. The temperature of the mould is a materialspecific parameter with a direct influence on the process and in particular on the cycle time. The mould temperature also influences the airflow, which is relevant to the injection moulding process in cleanrooms. The hot air radiated by the mould rises and therefore moves in the opposite direction to the cleanroom airflow which conventionally runs from top to bottom (Figure 1). As the temperature rises, the particulate load increases which puts the cleanroom quality at risk. Uneven airflow in the mould area can cause particle deposits on the parts because there is not enough clean air coming in to remove the contamination.
Figure 3: The cleanroom module with reversed airflow developed by Max Petek Reinraumtechnik fits space-savingly in the frame of the injection moulding machine
Influence measurable at 40°C A thesis investigated how effectual a conventional filter fan unit or laminar flow box was on mould temperature [1]. The experiments were carried out in Engel’s cleanroom. The LMP type laminar flow modules were provided by Max Petek Reinraumtechnik and were developed in the size used specifically for injection moulding machines. Two system conditions were used for comparative purposes: One with normal cleanroom airflow, and the other with the mould and ejector area encapsulated with an LMP. In both series of experiments, mist was added from above to the mould area to make the airflow visible for both systems. Mould heats were also held constant across both experiments. The simple experiemnt established that without an additional laminar flow module the mould temperature of 40°C influences the flow of clean air through the mould area. This outcome shows how important this research work is because such a low mould temperature can only be used for very few applications. 16
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Volatile components of the LSR are an additional contaminate to the cleanroom. The influence of mould temperature cannot be neglected.
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COVER STORY
Figure 2: A constant airflow no longer prevails at a mould temperature of 90°C. The turbulence occurs primarily directly after opening the mold. The airflow settles again after four seconds
The LMP was used to achieve an even more constant flow from top to bottom. The air velocity was set on 0.45 m/s in accordance with the EU GMP Directive. The mist tests in this encapsulated configuration were recorded in a video. The still images clearly show that a constant airflow no longer prevails and turbulence occurs from a mould temperature of 90°C and above (Figure 2). The turbulence occurs primarily directly after opening of the mould; the airflow settles again after four seconds and the flow through the mould becomes constant again. The same measurement was repeated at a mould temperature of 140°C. Here four seconds wasn’t enough to disperse the turbulence. At this high mould temperature, the complete air in the mould area is very hot, and particles are emitted in increased number. An adequate laminar flow can only be shown again at an increased air velocity of 0.8 m/s.
Mould opening speed a further adjustment parameter In addition to temperature, the mould opening speed also has an influence on the airflow. The airflows were investigated at opening speeds of 1100 mm/s and 220 mm/s. Tests showed that a slow movement of the mould mounting platen causes less turbulence than very fast opening of the mould. When, however, the extremes were tested, it was shown that excessively slow opening intensifies the air turbulence as the air between the mould halves heats up again during the slow mould opening. In contrast, extremely fast opening can stabilise the airflow so that the mould and injection moulded parts are constantly exposed to clean air. To depict these extreme speeds, mould opening times of 12 and 3 seconds were investigated. The optimal opening speed for the purposes of cleanroom reliability depends in each case on the manufacturing process and the mould. In practice, however, the flow effects cannot always be considered adequately when it comes to setting the opening speed. The
medical technology sector is also subject to strong cost pressure and cycle time is a decisive factor in profitability.
upwards (Figures 3). The thermal makes the mist cloud disperse and gain speed quickly.
The challenge of liquid silicone rubber
A simulation of the experimental setup was used to corroborate the test results using ANSYS software version R16.2 Academic. The calculations confirm the good result of the tests in the technology centre and make it possible to predict the behaviour when changes in the environmental conditions occur.
The previous experiments established an important baseline for further consideration of injection moulding processes in cleanrooms. The objective of a second thesis - building on the above - was to develop approaches on how to ensure a high class of cleanroom at high mould temperatures [2]. To be able to make assertions for extreme temperature conditions as well, experiments were conducted with liquid silicone rubber (LSR), not thermoplastics. A special aspect of LSR is that the material is cooled in the barrel, while significantly higher temperatures of 180°C prevail in the mould. Only at these high temperatures can LSR vulcanise and crosslink. In addition to the high mould temperatures, a further complicating factor is the fact that LSR outgasses during processing. At high temperatures silane is released, which can be seen as a cloud with the naked eye. These volatile components of LSR are an additional contaminate to the cleanroom and in the course of production can quickly exceed the limit defined for the respective class of cleanroom. The cleanroom in the Engel technology centre was set up in ISO Class 7 for the experiments for the thesis. Particle measurement after just a few cycles showed an excessively high concentration of particles with a diameter of 0.5 µm. A first approach to solve this problem consisted of encapsulating the mould area with an LMP in order to vaporise the silane cloud. However, the clean air was not introduced into the mould area from above, but from below. A downwards extraction, which is normal in cleanrooms, was to be used to remove the silane particles. Although this experimental setup was unsuccessful, a lower concentration of particles was measured than in the previous measurement, even though it did not yet conform to the requirements of the cleanroom class ISO 7.
Simulation confirms empirical research The idea of reversing the airflow was then implemented consistently in a second step. The clean air was not only passed from bottom to top, but the mist cloud was also sucked out of the mould area
Max Petek Reinraumtechnik has developed a cleanroom solution with reverse laminar flow on the basis of these results. The air is sucked upwards out of the mould area.
First industrial system built The results of the two theses show that the influence of mould temperature on reliable cleanroom operations cannot be neglected. The laminar flow is already disturbed at mould temperatures above 40°C. A mould temperature of 110°C was established as limit for a conventional clean airflow from top to bottom (without additional laminar flow module). Both empirical measurements and simulations prove that the particle load can be minimised by reversing the flow of clean air. Engel and Max Petek Reinraumtechnik have already implemented the results of this study industrially. The new solution has the potential to become standard for high temperature applications.
References
1. Denisa Costas, Analysis of the impact of process temperatures on the cleanroom airflow during the injecting moulding of medical grade high performance thermoplastics, thesis for the degree course in Medical Engineering at the University of Applied Sciences Upper Austria, Linz, Austria, 2015 2. Helene Schöngruber, Identification and analysis of thermal flux in the cleanroom during liquid injection moulding, thesis for the degree course in Medical Engineering at the University of Applied Sciences Upper Austria, Linz, Austria 2016
Room Temperature 22 °C
Mold 180 °C
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Mold 180 °C
Figure 1: The clean airflow conventionally runs counter to the thermal flux. At very high mould temperatures the clean airflow does not even reach the mould.
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Taking a fresh look at counterfeiting in pharma and medical devices: from root causes to current solutions
WEBINAR Date: Thursday 14th September 2017 Time: 13:30 BST, 14:30 CET, 08:30 EDT, 18:00 IST Price: Free How do I know if my pharma and medical devices are being counterfeited? And how do I take swift countermeasures when I am? As pharma companies have improved patients’ access to safe medicines, the value of pharma brands has grown. It is attracting not just investors, but also counterfeiters. The WHO estimates up to 8% of medical devices on the market are fakes, as are up to 30% of medicines. The rise of new technologies and more complex value chains have made fighting counterfeit medical products more challenging. Yet it is a priority for patient safety and brand reputation. Clariant, the global leader in speciality chemicals, and SICPA, a global provider of security solutions, have joined forces to bring protection closer to the medicine. In the process, they are helping healthcare companies re-think security for pharma products, including medical devices and pharma packaging. If you are in charge of your company’s brands or supply chain, come join us in this webinar. Among other topics, we will look at: •
The sources of counterfeiting
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The current landscape in terms of technologies
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Which tools are relevant in the market and how are they designed to achieve anti-counterfeiting?
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Counterfeiting of medical devices and pharma packaging: myth or reality?
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Is anti-counterfeiting embedded into your risk management?
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The fight against fakes: where do we stand?
Speakers: Steve Duckworth, Head of global segment medical & pharma, BU masterbatches, Clariant Plastics & Coatings Ltd Yaan Ischi, Director new channels and partnerships, SICPA SA Mark Davison, CEO, Blue Sphere Health
Register Now
www.medicalplasticsnews.com/webinars Can’t make the date? Sign up any way and we will send you an on demand copy after the event.
As one of the world’s leading specialty chemical companies, Clariant contributes to value creation with innovative and sustainable solutions for customers from many industries. Our portfolio is designed to meet very specific needs with as much precision as possible. At the same time, our research and development is focused on addressing the key trends of our time.
Medical Plastics News is the voice of the medical plastics industry. It is an essential source of business critical, highly relevant and unique intelligence, which stimulates thought leadership and nurtures an innovative and connected community of industry stakeholders.
MERGERS & ACQUISITIONS
Come together
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Lu
ick up any end-of-year prediction article in the medtech sector and mergers and acquisitions ranks highly. From one year to the next news of deals between high calibre companies operating in the medical Rahman looks at some device sector never fails to provoke discussion.
of the stand-out M&A activity to hit the medtech sector in the last year
As medtech companies look to future trends, the appeal of acquiring a business that offers additional revenue streams or enter new markets is highly appealing. DePuy Synthes Products, part of Johnson & Johnson Medical Devices Companies recently acquired Innovative Surgical Solutions (Sentio), which markets innovative nerve localisation technology for spine surgery. According to DePuy Synthes the acquisition underscores the business’ strategy of investing in what it describes as “faster growing segments with technologies that are designed to help improve patient outcomes and bring value to our customers”. “With Sentio’s nerve localisation technology, DePuy Synthes will strengthen its spine portfolio in decompression procedures as well as lateral surgery, and build a platform for future innovation in minimally invasive surgery,” said Ciro Römer, company group chairman, DePuy Synthes. DePuy Synthes has also splashed out on 3D printing technology from Tissue Regeneration Systems (TRS). TRS’ 3D printing methods will help enable DePuy Synthes to create patient-specific, bioresorbable implants with a mineral coating intended to support bone healing in patients with orthopaedic and craniomaxillofacial deformities and injuries. Depuy Synthes says that the acquisition brings exciting new technology with the potential to personalise healthcare solutions in trauma. “We are systematically investing in building a pipeline of 3D printed products,” said Römer. “The TRS technology, which will be added to the DePuy Synthes Trauma Platform, is the latest example of how we are working toward developing nextgeneration technologies that transform healthcare delivery with individualised solutions for patients.” It isn’t just medtech companies that are looking to acquisitions to increase opportunity. Allergan subsidiary, Allergan Sales recently agreed to acquire Keller Medical, a medical device company and developer of the Keller Funnel. This coneshaped, plastic funnel reduces surgeon and patient contact during breast augmentation or reconstruction procedures. “This is a natural complement to our world-class plastic surgery and regenerative medicine business, and marketing this innovative device further enhances our commitment to our customers and patients.”,” said David Moatazedi, senior vice president of Medical Aesthetics at Allergan.
Opportunities in digital devices The connected health market is burgeoning so it’s no surprise that many companies are eyeing opportunities in this space. Last year the major drug delivery player Phillips-Medisize announced the acquisition of Medicom Innovation Partner of Denmark and its subsidiary in Cambridge, UK. Medicom specialises in connected health drug delivery devices employs a staff of 90 specialists in Denmark and the UK. This means that Phillips-Medisize now employs about 500 engineers throughout its global design and development network with hubs in Struer, Denmark and Hudson, WI, USA to develop injectable and inhalation devices for the global market. Later in the year it was Phillips-Medisize itself which was the subject of an acquisition when global manufacturer of connectors and interconnectors, Molex, bought the company. Martin Slark, chief executive officer of Molex said: “PhillipsMedisize brings strong capabilities to Molex in the medical solutions market globally. Combining Molex’s expertise in electronics and our broad manufacturing presence with Phillips-Medisize’s talented and experienced team will help us better serve the growing needs of the global market for innovative connected health solutions.” Adding value to business and enhancing areas of production have been key drivers for many of the sectors M&A activity. Last autumn Nolato agreed to acquire Polish Grizzly Medical, which is involved in the assembly, post-processing and quality assurance of medical device components and systems. The company has been a supplier to and partner of Nolato Medical since the 1990s. “This is a relatively small but strategically important acquisition that boosts our capacity in the low-volume, clean roombased production segment, including assembly and postprocessing, giving us an even more comprehensive customer offering,” said Nolato president and CEO Christer Wahlquist. Other acquisitions throughout the year included Nelipak’s purchase of thermoforming company Computer Designs Incorporated. Operating under the name Nelipak Healthcare Packaging, Nelipak said the acquisition strengthens its commitment to the North American healthcare market. The rate of M&A activity shows little sign of abating as businesses look to build on existing success with additional services and products. For that reason companies that offer a strong growth prognosis or potential to provide a competitive edge are the ones that may well stand out as ripe financial picking.
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MERGERS & ACQUISITIONS
United front I
n May of this year the industry witnessed yet another merger and acquisition announcement between two medical companies. This has been a common drum beat the last several years no doubt. However, in this case, neither company was a major medical device OEM with a well-known industry name such as Medtronic or Boston Scientific. Rather both were boutique medical plastics companies with a particular set of channels within the medical plastics and medical device contract manufacturing supply chains:
OEMs to maintain focus on core business and product innovation efforts. When companies such as Abbott and St. Jude Medical, Medtronic and Covidien, or Zimmer and Biomet merge, the attention is often first directed at their own immediate synergies between the merging entities. This step we might label Phase I. Phase II or more likely a Phase III, addresses their supply chain efficiencies, and this is where the example of Spectrum Plastics Group bears relevance as a continuing sign of what the market is undergoing.
Pexco, the Alpharetta, Georgia-based specialty extrusion and custom plastics company with a growing position in medical plastics; and Kelpac Medical, the Wisconsin-based and largest medical tubing manufacturer in North America, merged and rebranded as Spectrum Plastics Group.
As OEMs continue to diversify their product portfolio to stay relevant in today’s growing healthcare space so must their suppliers and contract manufacturers. Spectrum, as suggested by the name that Pexco and Kelpac have chosen to unite their operations under, features a broad range of capabilities. Pexco and Kelpac had been long-time competitors in the fluid management tubing space. However, over the years both have been bolting on additional capabilities through acquisition. Private equity owned, Pexco acquired injection moulding and tight tolerance extrusion capabilities, whereas Kelpac added silicone, microbore extrusion, mass-market medical injection moulding, finished device and assembly services. The combined entity now features most major manufacturing processes relevant to the medical plastics and performance materials sector.
The merger case illustrates how the effects of consolidation at the major Matt Robida, Spectrum company level are impacting the supply Plastics Group, chain. The highly fragmented $25 billion explains how its recent US medical contract manufacturing and outsourcing market, of which merger highlights the 40% is spent on plastics and which is way in which medical estimated to be growing near 10% per consolidation is also year through 2020, is beginning to show hitting the supply chain the same signs of consolidation that the majors have been witnessing. Both private equity firms and investment buyers, which annually are quite active in the plastics manufacturing realm, as well as private or public Industrial strategic buyers, wishing to get in on the medical growth game, have been participating in and exacerbating this supply chain consolidation trend. In an environment of continued globalisation and higher demand for medical technology and services, medical OEMs are diversifying their product portfolio, scale-up operations and gaining market share to improve their negotiating power with hospital systems and the demands of a value-based healthcare model. Large medical OEMs are increasingly aware of contract manufacturing organisations and their capabilities of lower-cost, time sensitive and highly specialised solutions, permitting
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Behind the consolidation at the major OEM level, companies and their procurement professionals are looking to find ‘one-stop-shop’ suppliers for efficiencies. One-stop shops generally offer more value-added services than individual organisations, such as engineering, assembly, and supply chain capabilities, including vendormanaged inventory and a strong quality system. This driver is indeed part of the rationale behind Spectrum Plastics Group. Working with a manufacturer that has a full product, technology and manufacturing portfolio, in this case across medical plastics and material manufacturing, becomes advantageous for both the buyer and supplier. Buyers get access through a single point of reference to multiple manufacturing capabilities, whereas suppliers may maximise their exposure to target accounts and customers. Moreover, a consolidation of specialty suppliers provides greater leverage on approved supplier listings (ASLs).
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MERGERS & ACQUISITIONS
Key Stats/Thoughts: Notable consolidations
Medical Technology Revenues
Middle market and start-up firms have experienced strong revenue growth, as smaller firms (those outside the top 50) have more than doubled in aggregate size from $56.5 billion in revenue in 2010 to an estimated $129.6 billion in 2015. This segment has significantly outpaced the growth of larger players, increasing at a 17 percent CAGR versus a combined 3 percent for the top 50 firms.
Though the qualification process within the buyer-manufacturer relationship still remains site-based, and not necessarily at the corporate level, gaining access to the customer is the issue. A company such as Spectrum Plastics Group, when presenting as an approved supplier to a target account, has greater access to sell a wider suite of solutions on behalf of the full, consolidated footprint. The ability to introduce new solutions that may not have been possible before is a benefit to both buyer, at the engineering and procurement level and manufacturer. When a major OEM needs components or a final solution with multiple layers of complexity, it will want to engage CMO with a range of capabilities, to take the stress off of the OEM, whose core competencies may not be fully in the realm of specialised manufacturing.
“
Behind consolidation at major OEM level, companies are looking for ‘one-stop-shop’ suppliers, says Matt Robida, Spectrum Plastics
”
When Kohlberg & Company, a private equity firm based in New York specialising in middle market investing, acquired Pexco on behalf of Kelpac Medical, the opportunity to merge the two and create the Spectrum Plastics Group, offering the market a comprehensive suite of plastic and contract manufacturing technologies and services, was rich with consequences for the sector. They were participating in a trend the industry can expect to see a lot more of during the next several years. In a world where, according to the Organization for Economic Cooperation and Development (OECD), healthcare costs have been outpacing normal economic growth by 2% for the past 50 years, with no sign of a slowdown, one can expect this activity to continue . . . on both ends of the industry spectrum.
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CATHETERS
Design for life Ray Ledinsky, Teleflex Medical OEM, provides expertise on designing a catheter to achieve optimal performance
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n catheter design, the functional requirements of the application allow the designer to identify performance requirements such as flexibility, lubricity, kink resistance, column or push strength, and torque transfer characteristics. Development of an optimal catheter design requires a strong understanding of catheter technologies to achieve the desired performance characteristics. This article offers a layer-by-layer approach to several design considerations for your device. At its simplest form, a reinforced catheter design is composed of an inner liner layer, a central reinforcement layer, and an outer polymeric overlayer.
Inner layer: Liners When selecting a liner material, it is essential to consider both the benefits of a material and its design considerations. There are trade-offs with any material. The key is to understand what is critical for the catheter’s application. Here is a reference guide to selected liner materials. PTFE (polytetrafluoroethylene) BENEFITS: Best lubricity, lowest coefficient of friction of any fluoropolymer and thermoplastic Ideal for multi-durometer design Thin walls EtO and autoclave sterilization DESIGN CONSIDERATIONS: Requires manual assembly No Gamma or E-beam sterilisation Etching required FEP (fluorinated ethylene propylene) BENEFITS: Good lubricity Lower coefficient of friction compared to ETFE, HDPE, and Pebax More flexible than PTFE Single-durometer (continuous process) or multi-durometer Gamma, EtO, E-beam, and autoclave sterilisation DESIGN CONSIDERATIONS: Single durometer is most efficient when using a continuous process Etching required ETFE (ethylene tetrafluoroethylene) BENEFITS: Superior tensile strength and stiffness Higher lubricity as compared to HDPE and Pebax Single-durometer (continuous process) or multi-durometer Excellent impact resistance Gamma, EtO, E-beam, and autoclave sterilisation
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DESIGN CONSIDERATIONS: Only single- durometer is available when using a continuous process Etching required HDPE (high-density polyethylene) BENEFITS: Good lubricity Good adhesion Continuous process Gamma, EtO, E-beam, and autoclave sterilisation DESIGN CONSIDERATIONS: Not as lubricious as PTFE, FEP, or ETFE Only single- durometer is available when using a continuous process No etching require Adhesion is based on tie-layer technology Increased reinforcement options are possible Polyamides/Pebax BENEFITS: High material strength Good for thin-walled, high- pressure applications Single-durometer (continuous process) or multi-durometer Gamma, EtO, and autoclave sterilisation DESIGN CONSIDERATIONS: Only single-durometer is available when using a continuous process Can be manually assembled for multi-durometer process
Central layer: Reinforcement There are two distinct types of catheter reinforcement: braid and coil. Advanced partners should be able to offer you technologies for increasing the tensile yield of a reinforced catheter. These include the incorporation of longitudinal, reinforcing components in a variety of materials such as flexible, high-tensile, advanced fibres.
Braid reinforcement Excellent torque control is the primary driver of a braided catheter design. This can be achieved with braid reinforcement. Manipulation of the distal tip of a catheter, by twisting the proximal end, requires good torque transmission with little ‘whip’. A relatively linear response is a desired catheter characteristic for end-use applications. The wire size, profile, density (PPI), and braid configurations can be engineered to provide a great balance of pushability with good torque control. In some cases, multiple braid layers are necessary to meet the level of manipulation that is required.
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CATHETERS
The pitch of the braid pattern can also be modified, by section along the length of the catheter, to vary both the catheter flexibility and hoop strength. Materials used in the reinforcement can be metallic or non-metallic. As for metallics, the most popular is stainless steel. Nitinol, due to its kink resistance, is becoming popular in microcatheters. There are three common braid patterns typically used in catheters. Each pattern produces different levels of torque and kink resistance. Regular braid pattern is a common pattern that uses 16 wires in a one-under-two, over-two pattern. Diamond braid pattern also uses 16 wires but differs from the regular braid pattern in that it produces a twounder-two, over-two wire pattern. This pattern tends to provide better torque and more kink resistance than the regular braid pattern but also has a slightly higher cost. Diamond braid pattern, half load: By utilising half the number of wires, the diamond pattern can be produced in a one-under-one, over-one wire pattern. This pattern provides more torque than the regular diamond pattern but incurs a much higher cost due to the reduced wire load. Device designers are not limited to these three basic patterns. Several original equipment manufacturers can create custom-engineered braid and coiling variations. Now it is even possible to utilise variable pitch, continuous reinforcement that can vary performance characteristics along the length of the shaft. Also, there are novel technologies for connecting dissimilar sections of the shaft without sacrificing shaft flexibility or performance. Designers can create precise catheter characteristics by combining any number of diameters, reinforcements, and hardnesses.
Coil reinforcement Outstanding hoop strength, kink resistance, and good pushability are characteristics of coil reinforcement. Teleflex Medical OEM can provide discreet, coil-reinforced catheters, on a PTFE liner, using a laid-up assembly process. This is generally limited to a single pitch along the length of the catheter. A recent technology is continuous, coilreinforced assembly that allows the coil pitch to be varied along the length (variable pitch coiling). This allows differing amounts of flexibility and kink-resistance along the catheter shaft. A continuous-coil design, using an HDPE liner, is one of the most cost-effective, composite designs available for a catheter.
THOUGHT PROCESS: The development of an optimal catheter design requires a strong understanding of catheter technologies says Ray Ledinsky, Teleflex Medical OEM
Often there are trade offs required in the catheter design depending on the performance requirements. For example, higher torque can be achieved with a higher pick count* but this will reduce the flexibility of the shaft. Likewise, a larger diameter braid wire can be specified to provide more stiffness and torque, but this will impact the minimum wall thickness and flexibility. A flat braid wire will reduce the wall and increase the flexibility, but this will also reduce the torque. As a result, it is important when designing a reinforced catheter shaft to consider the performance requirements up front to assure that the design meets the needs of the user.
Outer layer – polymeric overlayers This selection of the outer layer material strongly influences tensile yield, stiffness, and catheter pushability. The outer layer may be multiple materials or durometers. To perform effectively, a reinforced shaft needs strong adhesion between the inner and outer layers. Delamination between these two layers can compromise the catheter’s functional performance. This limits the choice of outer layer materials to polar materials, because they can adhere directly to either an etched surface or a tie layer. Polar materials are also beneficial for adding a hydrophilic coating on the outer layer, as they provide better adhesion. Lubricity and durability are the key requirements for consistent performance from a hydrophilic coating. Lubricity provides for ease of device insertion and tracking to the treatment site while simultaneously reducing damage to the endothelial layer of the vasculature. The coating’s durability properties are critical to meet the reliability demands of modern catheter applications.
More construction elements for consideration We’ve examined the three, basic components of catheter design. By incorporating a variety of construction elements, manufacturers can create catheter shafts with unique features. A steerable catheter shaft can be produced with multiple steerable wires, enabling clinicians to maneuver the tip precisely in multiple directions. Clinicians must be able to position the tip in the right place so that they can deploy the device properly. Multi-durometer segments along the shaft and tip, with varying degrees of softness or hardness, can alter the catheter’s flexibility, bend radius, and deflection angles. Balloons, with thin walls and small profiles, can be added to the shaft tip to create innovative catheter dilation and delivery systems. Marker bands of high density precious metals— typically tantalum, gold, or platinum — can be positioned along the shaft and used as a guide to distinguish key areas along the length of the catheter. Flexible radiopaque markers are sometimes used in lieu of metal marker bands. Encapsulated with tungsten-filled Pebax®, these markers provide similar radiographic visibility, while being soft and pliable. A plethora of decisions go into producing highperformance catheters. At each step of the process, these decisions can positively or negatively impact the overall function of the device. In addition, taking a concept from a functional prototype to a marketable catheter requires in-house expertise, and superior design and manufacturing capabilities. Finding the right partner that can deliver along those attributes can go a long way toward a successful product launch.
{
* The pick count is expressed in picks per inch of length (PPI), which represents the number of times the wire crosses for every inch of shaft length. The higher the PPI, the more wire coverage is achieved.
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INSPECTION
MAIN AIM: Greg Hetzler, Laser Design, says that minimising production costs and decreasing manufacturing time is a common industrial goal
An inspector calls Greg Hetzler, Laser Design, a subsidiary of CyberOptics, takes a look at the importance of part scanning and inspection within the overall production schedule Why is efficient industrial part inspection so crucial to manufacturers? Be it for aerospace, automotive, consumer electronics or medical devices – there’s a shared aim to minimise overall production costs and decrease manufacturing times to ensure time-to-market goals are achieved. For companies to achieve overall reductions in cost and time, as well as ship products more quickly, it’s about looking beyond the manufacturing stage and across the end-toend workflow – from design through to delivery. Quality assurance, and within that, industrial parts inspection, is an essential aspect of this. Whether for in-process quality assurance, incoming and outgoing parts inspection on the manufacturing floor or in the metrology lab or engineering environment, the need for increased speed from the development cycle to improve time-to-market is a key goal among manufacturers. Efficient part inspection helps to meet this objective.
There has been an increase towards 3D scanning and measurement in part inspection. This must make things easier for manufacturers? That’s right, this is a move that is increasingly commonplace, yet the attributes and performance capabilities of the various options available for this application vary significantly. The win-win comes from any system that not only fulfils the actual functional requirement demanded of it, but also delivers the essential information accurately, incredibly quickly and via an extremely user-friendly process. Not every solution achieves the latter aspects, which can affect the ability to provide the allimportant reduction in time and costs.
For example, although widely-used, traditional coordinate measuring machine (CMM)-type systems, while very accurate, are historically slow and difficult to programme.
So it’s about finding speed and simplicity without compromising accuracy? Exactly – and the good news is that recent technology advancements in 3D scanning and inspection have made it possible to overcome the challenge of achieving speed, simplicity and accuracy simultaneously. If you’re a manufacturer, it’s worth doing your homework and researching the latest systems.
How does your own technology address the needs that you’ve outlined? When it comes to the scanning/inspection requirements of our customers, we’re tackling some of the most difficult 3D shape manufacturing applications in the world. To stay abreast of these needs, we recently introduced the CyberGage360, which we believe sets itself apart from anything on the market in terms of high accuracy scanning and measurement of complex parts. Our latest generation CyberGage360 is an ultra-fast metrology-grade, one-button, automated 3D scanning and inspection system, which is quite literally as easy to use as a microwave oven. With no need for complicated programming, it’s no exaggeration to say that anyone could be trained within one hour.
A microwave for quality assurance – that sounds interesting, how does it work? The CyberGage 360 conducts a highly precise 360 degree 3D scan of complex parts, accurate to seven microns*, while automatically WWW.MEDICALPLASTICSNEWS.COM
generating a full 3D inspection report in three to five minutes. During the process, the system collects 10 to 20 million data points (XYZ coordinates) – a genuinely simple operation to achieve an extremely complex inspection.
How exactly is it able to save so much time compared to alternative solutions like CMM systems? One fundamental reason is its fixtureless design. There’s no need to mechanically affix the part or for the user to turn it over during scanning to capture both top and bottom geometry; the CyberGage360 captures from top to bottom in one pass. The system rotates the part to scan from various orientations, collecting all data in a mechanically precise manner into a single coordinate system.
So, why is this time-saving so important to manufacturers? The ability to access essential data in just a few minutes enables any necessary design changes to be applied much more quickly. This in turn supports the drive to get products to market faster. When it comes down to it, reducing or eliminating unnecessary time and cost across the design and production process is surely a key focus for any manufacturer. Certainly, from speaking to our own customers, a common and primary quality assurance goal in meeting their objectives is to maintain a close eye on parts to ensure quality criteria is met. By doing this, material costs are minimised as wastage is reduced. Meanwhile, production time is upheld which means things are manufactured to schedule and time-to-market goals are achieved. * 0.007mm+ L/10000 25
STERILISATION
clean lines Choosing the right decontamination method for syringe tubs entering the filling line, by David Opie and Maura O. Kahn, Noxiliser The prefilled syringe market continues to grow. In the past, products that were not candidates for oral administration (like large molecule compounds) would be delivered in a multi-dose vial container. Today, many of these products are administered in prefilled syringes to reduce the risk of injury to healthcare workers administering the drug, to reduce the container overfilling, and to improve dosing accuracy (Daedal Research, 2013). To meet the growing demand, companies install low, medium and high-speed filling lines for a variety of production needs. The majority of filling lines installed each year are low to medium speed lines, filling 100 to 200 syringes per minute, or about one to two syringe tubs per minute (Lysfjord, et al., 2010). These filling lines are used for commercial product, clinical trial or pre-clinical products. High-speed filling lines are typically reserved for large volume products, where the filling lines can fill syringes at a rate of six tubs per minute. Automated methods of introducing the syringes into the isolated filling line include a biodecontamination process after the tubs are removed from the outer bags. In this article, the methods of syringe tub biodecontamination are reviewed.
Current methods There are various methods used for biodecontamination of the syringe tub prior to entering the filling line. The three most common are: alcohol spray and wiping; vapour hydrogen peroxide biodecontamination; and, electron beam (e-beam) radiation. These methods are described below. Manual alcohol spray and wipe The tubs arrive in the sterile barrier bag. The outer surface of the bag is biodecontaminated with a spraying and wiping process. Pros: Low capital equipment cost and no known byproducts on the syringes Cons: Manual, slow process; inconsistent process and lethality, and difficulty validating a manual and highly variable process Vapour hydrogen peroxide (VHP surface biodecontamination The syringe tubs are loaded into a biodecontamination airlock chamber (either in the outer bags or removed from the outer bags) (Vogt, 2010; Spolyar, 2010). Pros: Validation process is defined; same technology as used in many filling lines Cons: Capital cost of chamber; longer process duration, and VHP inability to reach complex geometries (in the folds of the bag or under the flap on the Tyvek lid) Electron beam radiationsSurface sterilisation With the e-beam system, the tubs are continuously loaded into the tunnel – typically at a rate of six tubs a minute (Spoylar, 2010). Pros: Continuous, high speed process; validation and dose requirements well defined Cons: Large capital cost and replacement cost of emitters;
additional space in manufacturing area, and radiation protection required After reviewing these biodecontamination methods, it is clear that a reproducible biodecontamination method is needed for low and medium speed filling lines. Nitrogen dioxide (NO2) vs. hydrogen peroxide (H2O2) study Noxilizer conducted a head-to-head study of nitrogen dioxide versus hydrogen peroxide biodecontamination processes to compare the lethality and cycle time of each process. The comparison testing used a biodecontamination airlock that is configured for both hydrogen peroxide vapour and nitrogen dioxide gas. An accurate comparison of the two sterilants was facilitated by using the same airflow rates, materials of construction, loading configuration and test environment. The syringe tubs were removed from the outer bag prior to being placed in the biodecontamination airlock. Preparing the microbiological challenge for both NO2 and VHP processes is described below: Biological Indicators (BIs) were made from segments of tub lids consisting of a portion of the Tyvek and tub material, which were welded together in the Tyvek sealing process. The Tyvek flap on this portion of tub was lifted and inoculated in the seam with a spore suspension and allowed to dry. (In practice, the area under this Tyvek flap is susceptible to contamination during handling and after debagging in the Grade B or Grade C area.) 104 Spores per cm of linear length of tub lid segments (this equals 106 per tub as tubs have a circumference of about 100 cm). In addition, stainless steel BIs (106) in Tyvek pouches were used throughout the chamber. The load consisted of 10 tubs placed in the 200 L transfer airlock, 5 tubs on the top shelf and 5 tubs on the bottom shelf. A tub BI was placed on the lid of each of the 5 tubs that were on the bottom shelf (See Figure 1).
BI 1
BI 2
BI 3
BI 4
BI 5
Figure 1. Diagram showing the arrangement of the tubs and the placement of the tub BIs. The top row of tubs are on a shelf, above the bottom row of tubs. The tub BIs are placed on top of the tubs on the bottom row.
In addition, stainless steel disk BIs with 106 spores in Tyvek pouches were placed throughout the chamber. This represents the standard method for developing and validating a biodecontamination cycle for hydrogen peroxide today. The tub BIs mentioned above present a more significant, yet realistic challenge, for biodecontaminating syringe tubs based on how the tubs are actually handled and the risk of contamination, especially in the Tyvek lid and tub lip area.
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STERILISATION
The exposure cycles used for both VHP and NO2 processes were ones that completely inactivated biological indicators with 106 spores. The parameters for these cycles are shown in Table 1. The sterilant concentration and humidity with the biodecontamination process for a typical NO2 cycle is shown in Figure 2. The microbiological results for the VHP and NO2 cycles completed are shown in Table 2 and Table 3, respectively. Table 1. Cycle parameters used to test tub biodecontamination. NO2 Process
Time (Min.)
H2O2 Process
Time (Min.)
Humidification to 60% RH
1
Dehumidification to 20% RH
10
Dosing (NO2 added, 10 mg/L)
1
Dosing (Injection at 4.5 g/min) 1
Dwell (NO2 circulated)
7
Dwell (Stabilization at 1.5 g/min.)
7
Aeration to 1 ppm
6
Aeration to 1 ppm
25
Total Process Time
15 Minutes Total Process Time
43 Minutes
Figure 2. Typical nitrogen dioxide sterilization cycle for syringe tubs. (The red and blue lines represent FTIR readings. The green curve indicates the measurement from the EC cells in the chamber. EC cells were included in order to measure NO2 at the lower levels, 1-10 ppm. Because of the sensitivity of the EC cells, they were not exposed to the chamber air until the FTIR results indicated that the NO2 concentration had fallen to 10 ppm or less.) Table 2. BI results for the VHP cycles. N indicated ‘negative’, or sterile BI. P indicates ‘positive’, or that the BI had viable surviving spores.
BI 1
BI 2
BI 3
BI 4
BI 5
8 min.
N
P
P
N
P
6 min.
N
P
N
N
P
4 min.
N
P
N
P
N
Time
BI 1
BI 2
BI 3
BI 4
BI 5
6 min.
N
N
N
N
N
4 min.
N
N
N
N
N
2 min.
N
N
N
N
N
Discussion
Time
Table 3: BI results for the NO2 cycles. N indicated ‘negative’, or sterile BI. P indicates ‘positive’, or that the BI had viable surviving spores.
The nitrogen dioxide cycle parameters of 10mg/L achieved lethality on all BIs at as little as a two minute exposure – even in the most challenging location, the lip of the Tyvek lid and tub area. This demonstrates that a 15-minute cycle in the Moduline – BioDecontamination unit will provide consistent biodecontamination, including a reasonable safety margin. The VHP microbiological results demonstrates that the biological indicators were not consistently biodecontaminated. As a result, the VHP biodecontamination process would require a higher dose of H2O2, or longer exposure times. Hydrogen peroxide failed to achieve consistent lethality results at the tub lid. While there was evidence that lethality could be achieved at eight minute cycles with the lesser challenge – stainless steel disk BIs in Tyvek pouches. One would suspect the spore inactivation rate (inversely proportional to the D-value) on the polystyrene tub material (tub BIs) would be larger than the D-value on stainless steel, as has been reported in the literature (Sigwarth, et al.). These results demonstrate that nitrogen dioxide provides a solution for the low and medium speed filling lines. The Moduline – BioDecontamination unit (co-developed by Noxilizer and Getinge, distributed by Dara Pharma) achieves lethality in the most challenging location when compared to VHP and is more cost-effective than an e-beam system. References Daedal Research, Global Prefilled Syringes Market: Trends & Opportunities (2012-2017), February 2013, page 7. Lysfjord, J., Porter, M., Final Survey Results 2010, presented at the ISPE Barrier Isolation Technology Conference, Brussels, Belgium, September 2010. Sigwarth, V., Stärk, A. (2003) “Effect of carrier materials on the resistance of spores of Bacillus stearothermophilus to gaseous hydrogen peroxide,” PDA Journal of Pharmaceutical Science and Technology 57: 3–11. Spolyar, James, “E-Beam Technology for Nested Pre-filled Syringe Tub De-contamination,” ISPE Central Canada Annual Meeting, September 30, 2010. Vogt, Oliver, “Case Study: Utilizing Electron Beam Surface Decontamination to Transfer Sterile Syringe Barrels into an Isolated Aseptic Syringe Filling Line,” Pharmaceutical Engineering, January-February 2010, pp. 1-8. Noxilizer Test Report: NR.052.00 – Prefilled Syringe Tub Decontamination Study, October 2015
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SOFT ROBOTICS
Bend me shape me M
ention robots and chances are most people conjure up Dr Who-style Cybermen or the automated machines like the ones we see in today’s car manufacturing plants. These hard-framed, human-like devices are a familiar sight using their metal limbs to imitate arms, or carry out repetitive tasks at both speed and with great accuracy.
Lu Rahman looks at the new wave of robotics. Soft and pliable these new devices take their inspiration from nature offering great potential for healthcare. Are we about to witness a new group of very useful and compliant, flexible friends?
But there’s a new wave of robots making their way into our imaginations and our lives. Soft and squishy and stretchy, these devices take a lead from nature while boasting the ability to squeeze and move in a more flexible and compliant manner. And the healthcare world is casting its eye on these flexible structures made of elastomeric material.
Soft robotics offer a new generation of technology – compliant, flexible material that mimics natural tissue and can be used to interact with humans. Powered by ‘artificial muscle’ these devices are the new frontier of automation and in the healthcare sector opportunities for this technology are immense and exciting – we’re hearing more and more about its potential life-changing applications. Last year Nature magazine reported on the work being carried out at the Sant’Anna School of Advanced Studies in Italy where Cecilia Laschi and her team studied the movements of an octopus and how it handled food – the idea behind this was to create a robot that could mimic those movements – twisting and shaping and wrapping, free from the rigours of computer programming and inflexible hard bodies. In the UK SoftLab Bristol, at the University of Bristol, is carrying out major research on soft robotics. Projects include artificial muscles using soft electro-active and chemo-active actuators, artificial stomachs and soft sensors. At the National Science Foundation (NSF) in Virginia, US, work has been done looking at the way polymer-based materials can be turned into artificial muscles. It’s thought that these novel robotic devices offer a range of benefits over conventional robots. Due to their flexibility, they could offer hope in a variety of healthcare situations, acting as replacement muscles for disabled people, for example.
The role of polymer With his team, Kwang Kim, University of Nevada and the NSF has been researching the development of artificial muscles using polymer-based material. Last year the NSF revealed that getting the material right is one of the biggest challenges. Kim’s team was using an ionic polymer-metal composite – the electroactive nature of the polymer allows electricity to be run through it so that the shape can changed – this of course is markedly different to conventional robots which require motors to move.
Soft hearted? Earlier this year Harvard University and Boston Children’s Hospital revealed some exciting work involving a customisable soft robot that fits around a heart to help it beat. The research has huge implications for anyone who has suffered heart failure. According to Harvard, the soft robotic sleeve, “twists and compresses in synch with a beating heart, augmenting cardiovascular functions weakened by heart failure. Unlike currently available devices that assist heart function, Harvard’s soft robotic sleeve does not directly contact blood. This reduces the risk of clotting and eliminates the need for a patient to take potentially dangerous blood thinner medications. The device may one day be able to bridge a patient to transplant or to aid in cardiac rehabilitation and recovery.” The device is attached to a pump that uses air to power soft actuators. Each sleeve can be customised for each patient and according to for example, the side of their heart where more power is needed. Ellen Roche, the paper’s first author and former PhD student at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) and The Wyss Institute of Biologically Inspired Engineering at Harvard University commented: “This research demonstrates that the growing field of soft robotics can be applied to clinical needs and potentially reduce the burden of heart disease and improve the quality of life for patients.” “This work represents an exciting proof of concept result for this soft robot, demonstrating that it can safely interact with soft tissue and lead to improvements in cardiac function. We envision many other future applications where such devices can deliver mechanotherapy both inside and outside of the body,” said Conor Walsh, senior author of the paper and the John L Loeb Associate Professor of Engineering and Applied Sciences at SEAS and Core Faculty Member at the Wyss Institute.
Soft wearable robots Not quite mimicking artificial muscle but none the less highly exciting for the future of healthcare, are soft wearable robots which combine the latest in textile science with robotics. Recently the Wyss Institute for Biologically Inspired Engineering at Harvard University collaborated with ReWalk Robotics to develop wearable exosuits for patients with limited walking ability. “This is a very exciting for soft exosuit technology,” said Conor Walsh, John L Loeb associate professor of Engineering and Applied Sciences at Harvard John
The robotic market is strong and offers great potential. According to Crystal Market Research, the value of the healthcare assistive robots sector is set to hit $1 billion by 2025. If the soft robotic develops there’s every chance it could have a significant slice of the financial pie. 30
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SOFT ROBOTICS
“
A team of researchers at the Wyss has created a highly sensitive soft capacitive sensor made of silicone and fabric that moves and flexes with the human body
A. Paulson School of Engineering and Applied Sciences (SEAS), founder of the Harvard Biodesign Lab and a core faculty member at the Wyss Institute for Biologically Inspired Engineering. The exosuit - a soft wearable robot - was developed at the Wyss Institute by Walsh and his team through prototyping that included the involvement of roboticists, mechanical and biomechanical engineers, apparel designers and software engineers. Using form-fitting, fabric-based designs that are lightweight and non-restrictive, the Wyss Institute’s soft exosuit uses compact, powerful actuators packaged in a belt to provide assistance to the wearer’s legs in a physiologically relevant manner. These enhanced movements have the potential to assist wearers in walking with greater stability and metabolic efficiency, which could prevent injury and reduce fatigue, the Institute said. Over the course of its development, the soft exosuit has been the catalyst for entirely new forms of functional textiles, flexible power systems and control strategies that integrate the suit and its wearer in ways that mimic the natural biomechanics of the human musculoskeletal system, according to the Institute. Larry Jasinski, CEO of ReWalk, said: “There is a great need in the health care system for lightweight, lower-cost wearable exoskeleton designs to support stroke patients, individuals diagnosed with multiple sclerosis and senior citizens who require mechanical mobility assistance.” Walsh scooped Rolex Award last year for his work. Given that globally 15 million people suffer a stroke each year, the product has huge potential.
Soft and stretchy sensors It’s not only robotics that are becoming increasingly flexible. And the Wyss Institute is once again behind a breakthrough. Wearable technologies have exploded into both healthcare and consumer markets. Recognising that most of the electronic sensors used in these devices are made from hard, inflexible materials, a team of researchers at the Wyss has created a highly sensitive soft capacitive sensor made of silicone and fabric that moves and flexes with the human body to unobtrusively and accurately detect movement. “We’re really excited about this sensor because, by leveraging textiles in its construction, it is inherently suitable for integration with fabric to make ‹smart› robotic apparel,” says Walsh. “Additionally, we have designed a unique batchmanufacturing process that allows us to create customshaped sensors that share uniform properties, making it possible to quickly fabricate them for a given application,” says Ozgur Atalay, postdoctoral fellow at the Wyss Institute. This research is published in Advanced Materials Technologies, and the protocol is available as part of the Harvard Biodesign Lab’s Soft Robotics Toolkit. Soft robotics offer great potential for our health and wellbeing. Free from the metal clad structures of conventional robots, these flexible designs herald a new future for healthcare and medical device pioneers seeking to push the boundaries in design. As Laschi commented in Nature magazine, “It’s a completely different way of building robots.”
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CLEANROOMS
CLEAN LIVING Sean Fryers, Connect 2 Cleanrooms, looks at off-site construction and the future of cleanrooms
O
nce you have established the need for a cleanroom it is important to consider which type of cleanroom you require. Traditional, modular, on-site or containerised systems are commonly adopted construction methods within the cleanroom industry. Modular cleanrooms are typically freestanding, solid and robust structures that are suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse. No longer seen as a temporary, low budget option, the modular cleanroom offers a reliable and robust alternative to traditional build cleanrooms. Using off the shelf proprietary components to build a facility that meets the customers’ exact requirements such as size, wall option including softwall, hardwall or monobloc panel systems, the bespoke modular cleanroom offers great flexibility to future relocation or expansion, allowing you to manage your investment in stages to ensure costeffective ROI. The on-site method of construction offers flexibility, so it can sometimes be difficult to control lead times and control costs due to changes to the specification that can occur mid contract. The reactive containerised or portable solution is ideal for disaster sites where a quick fix is required e.g. the Ebola outbreak or fire damage etc. The versatile design allows for convenient and rapid transport and installation just about anywhere. The introduction of the off-site cleanroom construction option is just one of the latest innovations to be introduced to the cleanroom industry by leading cleanroom manufacturer, Connect 2 Cleanrooms in-line with other industries / sectors, who are adopting this modern method of construction, seen by key players and the government as crucial to improving efficiency, cost, quality and sustainability.
The growth of off-site construction The use of off-site construction methods is growing internationally due to improved customer perceptions and its value in the UK is £1.5bn, which is projected to grow to £6bn (UKCES, 2013). This equates to 7% share of the construction industries £90bn annual contribution to the UK economy (HM government 2013).
or modules in a factory environment before installation into their final location of which four main categories are considered: Panelised systems or non-volumetric preassembly relates to items which are preassembled in factory-controlled conditions, are non-volumetric and do not enclose usable space eg. a door set. Modular or bvolumetric is the term used to describe units prefabricated in a factory that enclose usable space that are typically fully finished internally eg. plant rooms which are then installed within or onto a building or structure. Sub-assemblies & components refers to simplified components such as windows, wash stations and transfer hatches which are manufactured in factories. Hybrid systems are a combination of more than one system or approach and are normally a combination of volumetric and panelised systems, interlocked door systems or control monitoring systems. Also known as off-site prefabrication (OSP), offsite manufacture (OSM) and as a modern method of construction (MMC), off-site construction has been used in mass production of housing since the early twentieth century. The end of World War II adopted this new approach for the construction of new dwellings as temporary housing for thousands of urban families ‘bombed out’ during the World War II. A white Paper, published by the government in 1945 outlined the objectives to complete the slum clearance with the emphasis to supplement traditional building operations using industry capacity outside the building industry. Immediately after the war there was a surplus of steel and aluminium production from industries geared to war output. These factors drove the industry towards prefabrication and resulted in varieties of concrete, timber, steel and hybrid framed systems. The quality of prefabricated units has increased to the point where they may not be distinguished from those traditionally built. Off-site construction provides a safer working environment, as the accident rates in manufacturing are some 29% less for major injuries and 52% less for fatalities than traditional build construction sites. Therefore, moving construction activities to a factory environment should correspond to a significant reduction in the number of major injuries and fatalities which are recorded each year within the construction industry. (Krug, et al, 2013).
Internationally there is momentum to build more offsite and it has been identified by the UK government as a vehicle for the delivery of a more sustainable built environment. Building off-site is a change in construction culture towards a process of continuous improvement with enhanced productivity and as a result it requires being underpinned with research, innovation and training.
Pioneering off-site construction methods
There is a range of terms which have been used for offsite construction but fundamentally it is the manufacture and pre-assembly of construction components, elements
As the leading manufacturer in modular cleanrooms, Connect 2 Cleanrooms remain forward thinking, focussing on new solutions to ensure product quality and customer
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Sources:
Building Offsite. An Introduction by Dr Robert Hairstans, Edinburgh Napier University Offsite Production in the UK Construction Industry – HSE Offsite is key to construction 2025 – Building4Change
choice. With over 15 years’ experience they are pioneering new technologies in off-site construction, in-line with other industries. A first in the modular cleanroom manufacturing sector! Improved safety Low cost Low risk Improved timescales The off-site construction method can be used for a variety of cleanroom purposes including large open spaces with no internal supports. Using pre-fabricated panels in preference to the frame system, the apertures and fixtures will be prepared off-site to minimise time, reduce safety risks and minimise the need for the specialist trades on site, eg. electricians. Door systems will be delivered as hybrid systems with frame handles, glazing and interlocking systems in place. As a more cost-effective solution for clients the off-site method allows you to stay within your allocated budget and control lead times, as decisions are made well before the installation date. More time is allocated to the complex and critical design stage, which ensures accuracy and reduces the installation time on site, minimising business disruption, as well as offering a cleaner, safer and less congested site. Off-site construction offers a more accurate and timely installation with less chance of failure, with all elements being tested prior to delivery to site ensuring these cleanroom projects are completed on-time. McDonald’s use off-site constructed structures for its restaurants, and set a record of constructing a building and opening for business within 13 hours. Currently McDonald’s build 30 new restaurants per year in the UK using this method. More suited to major construction where areas are clear of equipment, the off-site construction method can be offered where a strong preference to GMP sectors is required, as the structure allows for a fully flush finish. This is achieved due to there being no ledges, using floor to wall, wall to wall and ceiling to wall coving and a fully bonded floor.
Due to being classed as a building and construction and subject to size, location and the local authority, consultation regarding building regulations or planning permission may be required. This can allow for longer depreciation of the asset creating lower monthly costs to your business. Depreciation time scales could be from 10 to 50 years.
Why choose off-site construction? The biggest advantage to off-site construction is thought to be the decreased construction time on site, together with increased quality, a more consistent product and reduced snagging and defects. Combined, this construction method can offer significant financial benefits through increased value, efficiency and sustainability. The reduction in installation time means less business disruption reducing or eliminating business process downtime. Along with increased quality, less snagging and defects, and reduced waste, this sustainable approach to offsite construction of cleanrooms is the future. Offsite systems correspond to a reduction in waste of between 20% and 40% (WRAP, 2008) Connect 2 Cleanrooms has demonstrated its experience within off-site cleanroom construction, following the successful installation of a large scale monobloc cleanroom, spanning 951m². With a requirement to achieve ISO class 8, the cleanroom includes a separate change area suitable for up to 60 operators and a material transfer area. The main cleanroom area, which was designed and installed for a global medical and technologies company to house their stitch bonding processes, has a footfall of 870m² and is designed to achieve 21 air changes per hour. Monitored via an ECO loop control system with temperature and humidity control, the cleanroom has 60 variable speed controlled HEPA ceiling fan filters, which are all accessible externally via the walkable ceiling for non-disruptive maintenance. The off-site construction method adopted for this installation ensured that the clients’ cleanroom was brought in on time, on budget, resulting in a happy client.
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DIGITAL HEALTH
Talking tech The rise of digital health is well documented. Ruth Wright, from intellectual property law firm Gill Jennings & Every LLP asks what makes a digital health business a medtech business?
T
hese days, with digital transformation and disruption on everyone’s lips, there is no shortage of companies across a range of sectors trying to claim to be a technology business as a badge of honour. It has never been more challenging to determine whether a company is genuinely a technology business or is simply ‘technology-enabled’. This may seem like mere semantics, but the difference is significant when it comes to dictating a company’s ability to protect its ideas. For digital health start-ups trying to gain a foothold in an increasingly crowded market, self-definition is an exercise which can inform whether its intellectual property (IP) strategy should be patent or brand-focused.
Founders and investors who are driving the growth of digital health are often from a traditional medtech background, where the need to publish trial data to gain regulatory approval makes early patent filings and aggressive IP enforcement policies essential. However, the nuances of the law around protection of computer-implemented innovations can mean that an IP strategy built around gaining a blockbuster patent can be risky for some digital health businesses.
Tech or tech-enabled?
Patentability
The test for determining whether or not a business is a genuine technology company is, in theory, fairly straightforward: does it develop technology? Much of the work of traditional companies in the fields of engineering, chemistry, and life sciences results in the development of tangible technological processes or things. This work will usually qualify for research and development (R&D) tax relief, and the output will often be patentable. In the digital world though, the answer is not always so obvious.
For an invention to be eligible for patent protection, it must meet five key criteria: is it capable of industrial application; is it new; does it involve a non-obvious inventive step; is it described in sufficient detail to allow others to replicate it following expiry of the patent; and does it consist of patentable subject matter?
In fact, the distinction can be harder to see if the business model being digitised is operating within a traditional tech field. In digital health for example, many start-ups are using offthe-shelf software or third-party designed ‘white label’ platforms to start generating revenue immediately and with minimum 36
capital investment. So, just because an app sends you a notification to remind you to take some medication which resulted from years of rigorous research, does not make the app developer a medtech business.
When it comes to what is considered patentable subject matter, there are specific limitations for computer programs. If the software merely implements a business method, it is generally not patentable in most jurisdictions. If it controls a technical process however, it may well be patentable, and innovations that solve technical problems in the real world are also likely to be patentable. To obtain a software patent it is necessary to show that the effect of that software goes beyond a mere operational advantage, and has some technical impact.
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That said, the law itself, and more practically the way that patent offices implement that law, is still in flux, having yet to fully adapt to the digital world. Further, just because your patent was granted in the US does not mean that you will get the same result at the European Patent Office. Even within patent offices, different examiners can take different views, and challenging an unfavourable opinion, however unfair, can be expensive and timeconsuming. It is therefore crucial to take the time to determine at an early stage whether patent applications will be valuable assets, or just a drain on resources.
IP strategy Innovative businesses should always take the time to consider how best to protect their ideas, and thus their market share and valuation. For true tech companies, patents can provide robust legal protection for investment made in R&D. For technology-enabled businesses however, a focus on establishing a trusted brand, and protecting it using trademarks, may be more appropriate. ‘Tech’ is a label which has been too liberally applied by start-ups looking to ride the wave of the fourth industrial revolution. Calling practically any applications-based and technologyenabled business with a link to medicine, health or wellness a medtech company is about as useful as calling all the enterprises of the first industrial revolution ‘factory companies’. While these labels can accurately describe an aspect of what such businesses do or how they do it, when used so loosely they don’t help innovators to identify their USP, and form a coherent strategy around it.
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r As the femtech ma a ch opens up, there’s ea it could have hug to younger wome career options
Girls just wanna have… femtech I
’ve worked in the medtech sector for over three years and in that time, it’s still a male dominated world at the top. Visit some trade shows, exhibitions or conferences and sometimes you might wonder where women in the women are.
The lack of high-ranking medtech positions is nothing new. But is there change on the horizon? With the rise of a new sector dedicated to female health products and devices – femtech – Lu Rahman asks whether this might help boost the number of women in healthtech careers?
It’s a strange one. In many areas of science women are well represented. Take medicine. According to the Kings Fund, numbers of women in medicine have grown considerably in the last 15 years and now make up more than half of all medical students. But when it comes to technology-based healthcare, or running medical device or medtech businesses, the number of women holding board-level jobs is disappointingly low.
According to the Joint Council for Qualifications, the uptake of STEM GCSE subjects in boys and girls, is largely equal. However, only 20% of physics students at A level are female and only 9% of the female engineering workforce is female, says the Women’s Engineering Society.
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Last year WISE, the campaign for gender balance in science, technology and engineering in the UK looked at the number of women on FTSE 100 boards. It noted: “In this year’s list, there are only six companies across the FTSE 100 with only one woman on the board and 60% of companies now have more than two women on the board of directors. Within the STEM sector the number of companies reaching this milestone has increased significantly since 2015. However, the STEM sector still lags behind the non-STEM sector where 65% of companies have hit this benchmark.” In the US, Rock Health’s The State of Women in Healthcare reports are worth reading. In 2015 Halle Tecco, covered an update on the report: “Despite making up more than half the healthcare workforce, women represent only 21% of executives and 21% of board members at Fortune 500 healthcare companies. Of the 125 women who carry an executive title, only five serve in operating roles as COO or president. And there’s only one woman CEO of a Fortune 500 healthcare company.
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market a chance ge appeal omen’s ons.
FEMTECH: WOMEN AND HEALTHCARE
“We know from our funding data that women make up only 6% of digital health CEOs funded in the last four years. When we looked at the gender breakdown of the 148 VC firms investing in digital health, we understood why. Women make up only 10% of partners, those responsible for making final investment decisions. In fact, 75 of those firms have ZERO women partners (including Highland Capital, Third Rock, Sequoia, Shasta Ventures). Venture firms with women investment partners are 3X more likely to invest in companies with women CEOs. It’s no wonder women CEOs aren’t getting funded.”
Importance of role models It’s disappointing reading and it would be easy to focus on the negatives. However, one of the key drivers to encouraging females into top jobs, is the ability to draw upon positive role models. The life science and medtech industries might not boast the same level of female numbers as the medical profession but there is a raft of women in high level careers providing inspiration for the younger generation to consider a healthtech-based career. The WISE website is a great source of information and inspiration. Featuring role models such as Siobhán O’Connor, lecturer in nursing informatics, University of Manchester, it helps encourage young women into science tech -based roles. O’ Connor says: “In particular, the digital health field has been growing exponentially over the last number of years. Even though it is still in its infancy the possibility of applying all sorts of technology, from mobile apps, to various Internet services, social media, wearable technologies and the emergence of Big Data and the Internet of Things, is huge and is why I now love working in health technology.”
Is the answer femtech? There’s a new term on medtech tongues, femtech – health technology aimed at the female market. We’ve seen years of products dedicated to the male section of society but with more or less half the population made up of women, there’s clearly an unmet need. According to Venturebeat the term femtech came from Ida Tin, founder and CEO of Clue, a period tracking app. As materials become increasingly sophisticated and sensor technology continues to advance, these can be used in a range of medical devices and wearables aimed at the female market, particularly pregnancy and family planning. And the femtech market is big business – said to be worth $55bn in 2015 by KPMG. Products such as the Priya Ring highlight how the market has taken advantage of technology. Described as offering a ‘level of precision that no other ovulation prediction method can’, the ring device features a sensor that monitors temperature to detect changes that take place before ovulation, alerting the wearer when they are at their most fertile. Stella Wooder, head of project management, Team Consulting, has picked up on the rise of connected female devices. She commented: “Connected devices focusing on women’s health are still relative neophytes, and it is not yet clear what the future holds. My prediction (perhaps more of a hope) is that connected devices may help make ‘routine’ screening programmes for cervical cancer, chlamydia and HPV, for example, more robust.” The cervical cancer market is a significant opportunity for connected medical devices. One of the most recent to hit the headlines has been the ‘pocket colposcope’ developed by a team of researchers at Duke University, North
Carolina. When the digital health disruption first arrived, patient empowerment was a real buzz phrase and this device aims to do just that. By connecting to a laptop or a smartphone, say its developers, it could eventually be used by women to self-screen for cervical cancer. According to the university, over 80% of the volunteers that tried the device said they were able to get a good image. As the femtech market opens up, there’s a chance it could have huge appeal to younger women’s career options. There are already many women heading up some of these new and exciting companies. The brains behind the Ava fertility bracelet is Lea von Bidder. Designed for personal and professional healthcare use, the bracelet is designed for women who want to monitor their health when trying to conceive. Speaking to About Time magazine, von Bidder outlined her journey in femtech: “I deeply care about women’s health and see it as one key component to women’s empowerment – this cause has always been something that deeply mattered to me. My interest and involvement has increased since I left university for the professional world, where we still clearly experience the lack of women in higher positions and founding roles. Helping women manage their cycle and giving them accessible, precise insights about their health and wellbeing won’t solve workplace equality issues, but it can help.” Tania Boler is one of the co-founders of Chairo and a clear role model for the younger generation. With a Phd in women’s health, and having held a range of leadership positions such as global director of research and innovation at Marie Stopes, and team leader for HIV prevention at UNESCO, Boler is behind the Elvie, a connected silicone device designed to improve women’s pelvic floors. The product has received extensive media coverage and fans apparently include Khloe Kardashian and Gwyneth Paltrow, according to City AM. In an article with the site, Boler’s insight into women’s healthcare highlights why the female perspective is valuable in this area. “Medical devices, particularly for women, are kind of really uncomfortable, difficult to use, very utilitarian in their design so for us what we’ve done with the first product and what we’re doing for future products is all about taking kind of neglected medical devices and turning them more into consumer products that people like to use,” she told Francesca Washtell. Similarly, CEO of The Flex Company, Lauren Schulte, used her own desire to find an alternative to the tampon, to create a medical device company. She told Forbes: “In the last 80 years, we’ve put a man on the moon, we’ve invented television, we’ve invented the internet, we’ve mapped the human genome, and we’ve still seen no change. The tampons that were made in the 1930s are still by and large the same product that we use today.” The Flex is made from medical-grade polymer and has been designed to offer a range of advantages over normal tampons. According to the Independent, the company, which has had wide-ranging media coverage, raised over $4m (£3.06m) in 2016. Things may not be about to change overnight but the growth of the femtech market may hold real potential when it comes encouraging young women into medtech careers. The future of femtech looks exciting and the more we can do to boost the number of females into healthtech careers, the better. Let’s hope that over the next three years, we start to see a real change in the sector.
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TUBING
The layer effect: Raumedic develops solutions by multilayer extrusion, making medical products from infusion tubing to filling tubing, safer and more efficient
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oextrusion and multilayer extrusion make it possible to use several different materials in one single tubing, providing a modern, Gert Walter, Business effective and in optimised Unit Tubing, Raumedic, practice, solution that can be discusses coextrusion used in a range of technology and its potential medical applications. for opening up areas of Polymer specialist develops medical applications Raumedic solutions by multilayer extrusion, making medical products from infusion tubing to filling tubing, safer and more efficient.
The role of coextrusion in medical engineering The use of multicomponent technology under cleanroom conditions provides an excellent foundation for the development of new medical and pharmaceutical products. As well as improved cost, the objective is to achieve improved functionality in new tubing products with the help of coextrusion technology. And while multilayer extrusion for the production of films in applications like food packaging no longer represents a significant challenge for modern tool and machine technology, coextrusion of multiple polymer layers in the production of micro-dimensional tubing for medical engineering is still uncharted territory in many cases. Nowadays, microextruders are able to produce multilayer tubing from up to four different polymer materials. The smallest achievable inner tubing 40
diameter is about 100 µm, with a minimal wall thickness of approximately 50 µm. Microextruders can work at minimal material throughput rates, with an output of less than 30 grams per hour. The advantages of coextrusion processes for medical engineering are obvious: l Application-specific distribution of layer thicknesses l Embedding of several colour stripes and x-ray contrast stripes l Integration of functional layers eg for light protection properties or gas barrier l Use of bonding agents for incompatible polymers against delamination
Suitable materials for multilayer tubing
Drug-compatible infusion tubing for highly sensitive drugs For decades, soft PVC has proven its worth as an efficient and easy-toprocess material for flexible infusion lines. Even today, well over 90% of all infusion tubing is made from soft PVC. With advances in the development of highly effective new drugs however, especially in oncology, an increasing number of problems have arisen involving drug compatibility with the PVC tubing material. Many highlysensitive drugs are adsorbed on the tubing’s surface, with the result that only a fraction of the intended dose actually reaches the patient. IN THE BAG: Connector tubes for infusion and dialysis bags
In theory, any polymer can be used in coextrusion. In practice, however, those thermoplastics are used that have already proven their worth in other processing techniques in medical engineering and pharmaceuticals: polyurethanes, polyamides, polyolefins, thermoplastic elastomers, and to some extent soft PVC as well.
Multilayer tubing for medical applications To protect light-sensitive solutions and ensure loss-free dosage of sensitive drugs, Raumedic has developed the products Rausorb, Rauinert and Rausonert. These three examples of medical engineering reflect the growing importance of multilayer extrusion.
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TUBING
Conversely, ‘undesirable side effects’ may occur, if plasticizers and other additives are released from the PVC material by the infusion solution. This happens most often when the infusion solution contains fatty substances or lipid-like solubilizers.
SENSITIVE TYPE: Raumedic Rausorb is for light-sensitive solutions MAKING GAINS: Raumedic Rauinert allows for loss-free dosage of sensitive drugs IDEAL SOLUTION: Raumedic Rausonert facilitates loss-free dosing of light-sensitive solutions
Optimised application of soft PVC in multilayer tubing In order to continue using soft PVC as a safe material in the production of multilayer tubing despite these challenges, Raumedic has developed Rauinert. The layering most commonly used with this product consists of an LDPE inner layer, an EVA bonding agent and a PVC outer layer. Polyethylene is chemically neutral in contact with the flow-through medium. The EVA middle layer serves as a bonding agent between the LDPE and PVC layers, since those two materials would not otherwise form a strong bond to one another in the coextrusion process. The outer layer made of soft PVC ensures that the manufacturer of the final infusion tubing sets is able to conduct all of its processes just as he would with any ordinary PVC tubing. This includes bonding, packaging and sterilisation, for example. The market share of this type of highlyspecialised multilayer tubing in infusion therapy is expected to grow in years to come. At the same time, new ideas are also being implemented. Compared with other production methods, multicomponent extrusion technology offers immense freedom in form and design, through its combination of multiple polymeric materials with the integration of additional functions.
Protecting light-sensitive pharmaceuticals is increasingly important Pharmaceuticals that are activated by exposure to light, or that break down in a photochemical reaction are increasingly used for special therapies. Substances like vitamin A and sodium nitroprusside take their activation energy from visible and invisible light in different ranges of wavelengths. To provide the required protection for these substances, the development of black tubing seemed to solve the problem. This, however, makes it impossible to monitor the infusion solution. As a result, any gas bubbles, impurities or other problems cannot be detected when they occur. Other solutions available on the market involve transparently coloured tubing, or windowed tubing made of a clear material including semi-circular segments of light-proof coextrusion
Filling tubing for PVC-free infusion bags As with food packaging technology, the trend towards the use of lightweight, flexible and unbreakable polymeric materials is developing in containers for infusion solutions, too.
materials embedded in the tubing wall. But these solutions are merely a compromise at best, since they do not comply with the applicable pharmacopoeias and relevant standards.
A solution for light-sensitive drugs Multilayer tubing from the Rausorb line meets medical engineering requirements. The inner layer of this special tubing is physiologically harmless. The outer sheath is infused with light-absorbing substances that correspond to the spectrogram of each individual infusion solution. With this technology, any chosen combination of wavelengths in the 220–800 nm range can be largely filtered out. Since each preparation is only sensitive to a very specific set of wavelengths, there are enough ranges remaining to allow for the production of transparent tubing that still blocks all but a negligible amount of light in the critical wavelength ranges. This makes it possible to develop tubing that is specific to individual drugs.
Loss-free dosing of light-sensitive solutions For drugs that are both lightsensitive and PVC-incompatible, the Rausonert tubing line offers customtailored solutions – with regard to the requirements of later processing steps as well. Inert inner tubing layers are coextruded with light-absorbing outer layers. The possible combinations of materials and dimensions are virtually unlimited.
For infusion bags, the first step was the use of PVC films, tubing and connectors containing plasticisers. Since the early 1990s, there has been an intensive search for alternative materials free of plasticisers and chlorine. For films, the industry quickly achieved adequate levels of quality that had already proven their value in the food industry. The films in question were multilayer films made from polypropylene or polyethylene/ bonding agent/polyester that comply with the requirements for transparency and ability to be sterilised with water vapor at 250 °F (121 °C). These PVC-free film bags require special filling tubing that is now produced in coextrusion technology. In developing these types of tubing, the goal was to provide an outer layer with good thermal weldability with all common films. At the same time, the inner layer should also provide excellent bonding to all common connector materials, such as polycarbonate, polypropylene or hard PVC, during the steam sterilisation process. Naturally, this combination of properties cannot be achieved in a single polymer formulation.
Construction of filling tubes for infusion bags This special two-layer tubing is composed of an inner layer of ethylenevinyl-acetate-copolymer (EVA) and an outer layer made of thermoplastic elastomer (TPE). The EVA provides excellent bonding to polycarbonate connectors, but must be cross-linked in order to maintain its shape at 250°F (121°C). If polypropylene connectors are preferred, three-layer tubing with a soft PP/soft PP/TPE layering can be used. With this layering, the modified polypropylene in the inner layer provides good bonding to PP injection ports, while the flexibility or stiffness of the tube as a whole can be variably controlled through the formulation of the soft PP middle layer.
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OU R E
Bob Donohue, Natvar, a Tekni-Plex company, explains how the new generation of microextrusion medical tubing opens doors to new procedures
Typically, extrusions were designed to assist with procedures from ‘the neck to the knee’. Tubing manufacturers could not extrude with tight enough tolerances to access the smallest arteries found in the head or below the knee. That meant certain life-sustaining, neurovascular interventional therapies and surgical procedures were often difficult. What was once called a microextrusion—typically a .015 inner diameter (ID) x .055 outer diameter (OD)—is now considered a standard extrusion. What used to be outlier dimensions are now considered common. In the past, these micro tubes were produced out of glass or, in the case of fluoropolymers, involved a secondary stretching operation to achieve the desired ID and OD. However, advances in plastic extrusion technology have changed the game. With minimally-invasive surgery becoming the wave of the future, microextrusion is allowing device manufacturers to provide products that otherwise would be difficult to achieve or expensive. The latest microextrusion tubing can now help OEMs develop complex devices that can provide therapies and treatments not previously possible for hard-to-access extremities.
Unrealistic requests become reality As is typically the case, development of new technology is driven by need. Medical device manufacturers pushed the envelope by asking suppliers to develop tubing with tighter tolerances that were significantly outside the norm. The need to miniaturise, enable implantable devices and make possible procedures that were previously thought to be impossible, were the drivers. What was initially considered an unrealistic expectation for the plastic extrusion process eventually turned into a reality as technological inroads on the processing side were made.
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ecause of new technological developments, the definition of what constitutes microextrusion medical tubing has shifted. As a result, both medical device manufacturers and patients stand to greatly benefit.
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Today’s new microextrusion definition is an ID size in the 35 microns (or .0014 inch) range, with very thin walls and extremely tight tolerances to meet the needs of newer invasive applications. Now that extrusion technology (both process and equipment) has caught up with the needs of the medical device industry, the latest microextrusion tubing can now be made in a one-step process from less expensive materials. The latest die designs, pressure transducers and high-end, inline, closed-loop controls, are a few of the many breakthroughs that have contributed to the development of thermoplastic microextrusion tubing. Consistently achieved tight tolerances are now allowing manufacturers to deliver performance attributes that were previously out of reach. It is also important to point out that multilayer microextrusions in catheter applications is another main driver behind these developments. Being able to use microextrusion technology in combination with coextrusion technology adds many new options for OEMs. This can allow for a highly lubricious inner surface (for device insertion), along with steerable characteristics, by modifying the outer shell of the catheter. This technology allows for the use of radio opaque indicators to be incorporated into the design without affecting performance.
New possibilities Natvar has made a considerable investment in a manufacturing facility to produce the latest microextrusion tubing. Available are monolayer, coextruded (up to four layers), multi-lumen tubing or profiles in a variety of thermoplastic (PVC, urethanes, TPEs) materials at CPK values above 2.0. (The CPK value indicates how close a process is running to its specification limits, relative to the natural variability of the process. The higher the index, the less likely it is that any item will be outside the specifications. As a frame of reference, a CPK of 1.33 or better is what medical device companies typically require.) Natvar’s new microextrusion tubing comes in wall thicknesses ranging from .003 to .005 inches.
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TUBING
Cost profile The ability to create microextrusion tubing from thermoplastics means that medical device companies can realise desired performance attributes at a fraction of the cost associated with fluoropolymers and glass. Multi-channel (or multi-lumen microcatheters) can aid in reducing cost by incorporating more than one device in a single structure. As microextrusions are being developed and enhanced, so are the devices that are used in conjunction with these structures. Fibre optics, guide wires, sensors and stents are a few examples that up until now were limited by size. This was due to the lack of extrusion capability needed to make these types of devices possible.
Psychological aspects of patient care It is also important not to overlook the psychological aspects of patient care. Advances in medical devices and therapies supported by microextruded tubing can go a long way in potentially enhancing the patient’s comfort level and recovery time. Discomfort and recovery can be minimised if procedures are less invasive and more therapeutic.
Precision provides significant performance, production impact The ability to consistently manufacture microextrusion tubing in tight tolerances impacts both device production, as well as patient satisfaction. Catheters, for example, are typically tip-formed and punched. When there are wide tolerance variances, the consumer experience will not be consistent each time he or she needs to catheterise themselves. One catheter tip may be painful upon insertion, while the next one might not be. Lack of consistency can result in consumer discomfort and stress in not knowing what the next usage experience will bring. When microextrusions are able to hold tight tolerances, then catheters are consistent and so is the consumer experience. There are other applications, such as those where precise delivery is required, where tight tolerances also can have a positive impact. A good example to look at is a tube used for wound therapy. In this application, medication needs to be precisely administered to the wound area. Traditionally, liquid has been pushed through the tube to see how much volume was coming out. The tube would then be cut to get to the approximate correct volume. This
less-than-precise way of delivering medication was the workaround used to compensate for an ID that was not in tight tolerance. Conversely, when the tube consistently delivers tight tolerances throughout its production run, then you are able to eliminate the delivery guesswork. It also benefits the device manufacturer by enabling higher throughput.
Speed-to-market In order to help OEMs meet their commercialisation objectives, it’s important to partner with a supplier that can assist in getting validations correct on the first try. For many years, medical device manufacturers have had to modify their manufacturing process to accommodate out of spec tubing. This resulted in a less-than-efficient process which frequently had a negative impact on speed-to-market objectives. It’s important both for device functionality and production efficiency to work with tubing that consistently delivers tight tolerances.
Global supply capability With a significant number of medical device companies marketing their products across the globe, an international supply pipeline can be critical. Not only should OEMs consider the supplier’s capabilities, but they should take a good look at their global manufacturing footprint. Medical device manufacturers want access to exactly the same components and materials regardless of where in the world their manufacturing facility is located.
Potential applications Potential applications for the latest microextrusion tubing are extensive and include both implantable devices and minimally-invasive procedures. Possibilities include: Heart leads Connecting a pacemaker to the heart muscles. Neurological Treatments for stroke patients where micro stents need to be inserted into the vascular system to open capillaries to eliminate blockage. Vascular Below the knee procedures such as arterial drills to assist in blood flow below the knee that has been compromised by diabetes. Catheters Traditionally, heart catheterisation procedures use the femoral artery in the leg to access the body. Microextrusions would enable smaller devices to enter the brachial artery and aid in expanding smaller vessels that have potential blockage. With the capability to get into the smaller veins, as well as the larger ones, more of the heart is accessible. In vitro fertilisation The new microextrusion technology can assist with a critical step of the in vitro fertilization process that enables the nucleus of the egg to be harvested more precisely. Infant/paediatric care The effectiveness of miniature devices, such as microcatheters that are engineered for the youngest among us, can also benefit from microextrusion tubing. Additional opportunities exist for treatments in the following areas: chemotherapy, auditory, ophthalmic, wound care, spinal therapies and others where smaller diameters and tight tolerances are necessary to achieve product objectives.
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Five femtech companies worth watching… Elvie – femaleled UK company developing tech including popular pelvic floor products
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Ava – the fertilitybracelet from the Swiss-based start-up
The Flex Company – using her own experience CEO Lauren Schulte has created a tampon replacement
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Wink - an oral fertility thermometer that syncs to the Kindara app
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Prima-Temp – the personal fertility sensor
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group of researchers from UCSD believe they have cracked the 3D printing of whole blood vessel networks. The artificial networks are functional and were even introduced into living subjects.
Q: Who are the innovators in 3D printing? A: The University of California San Diego
But this is not your standard 3D printing method. The process makes use of a series of mirrors and UV light. A UV pattern of the cell network to be printed is then shone onto a solution of living cells and light-sensitive polymers. The structure then solidifies under the light. The 3D polymer frame allows the living cells to grow naturally around it. The Georgia Institute of Technology and the Piedmont Heart Institute The Georgia Institute of Technology and the Piedmont Heart Institute in Atlanta has announced a collaboration to develop 3D printed heart valves to help surgeons in planning their procedures. When replacement valves don’t fit properly in heart surgery, the outcome can be fatal. 3D printing allows the surgeon to test it for fit, as well as function.
STICK WITH THIS: NEW PATCH GIVES VACCINES THE NEEDLE
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e all know someone who doesn’t like needles but thanks to a dissolvable patch, they may not have to fear having a flu vaccine injection. Researchers from Emory University and the Georgia Institute of Technology have developed a sucrose and polyvinyl alcohol patch – that contains 100 microscopic needles - to deliver a vaccine into the skin. The first human trial of the patch involved 100 adults aged between 18 and 49 who had previously chosen not to
get the flu jab. Participants were divided into four groups, one of which received an injection whilst the others wore the microneedle patch for twenty minutes. Of these three groups, one received a placebo and two were given the flu vaccine. Results of the trial showed that 96% of participants vaccinated with the patch found the process to be pain-free. Other results show that the patch provided strong immunity and that 70% of those receiving the patch preferred the method to traditional injections.
Check out... CroíValve’s minimally invasive device has been designed to help treat defective heart valves.
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t has been designed to treat tricuspid valve regurgitation, a condition where the tricuspid heart valve doesn’t close properly, causing the blood to leak backwards. The condition affects over half a million people
every year in the EU and US. The company is based at Trinity College’s Centre for Bioengineering and expects to spinout from the university in 2018. CroíValve chief executive Lucy O’Keeffe, said: “Surgery is too high risk for these patients so our device is delivered using a technique similar to that used
to implant a pacemaker. Once in place, our device works in tandem with the native valve to prevent backflow.” The device was funded by private investment and commercialisation grant of €500,000 from Enterprise Ireland. The company is now launching a multi-million funding round to help promote the device.
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